Perforated Marginal Ulcer After Gastric Bypass (PerforatedMU)

This study has been completed.

Sponsor:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01041196

First Posted: December 31, 2009

Last Update Posted: January 1, 2010

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A common late complication after gastric bypass surgery is marginal ulceration that is defined as ulcers at the margins of the gastrojejunostomy, mostly on the jejunal side. Most marginal ulcers respond to medical therapy and complicated or complex ulcer disease warrants operative intervention; specifically, perforated, penetrated, obstructing, bleeding and intractable marginal ulcers require surgical intervention.

Diverse operative strategies for addressing perforated marginal ulcers after gastric bypass have been described including I) Omental (Graham) patch repair, II) Revision of gastrojejunostomy, III) Irrigation and drainage, IV) any previous procedure with truncal vagotomy, V) Esophagojejunostomy, and VI) Reversal. We formally analyze our experience with the laparoscopic resection and repair of acutely perforated marginal ulcers after Roux-en-Y gastric bypass (RYGB), with or without concomitant resolution of technical risk factors for marginal ulceration.

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Morbidity and mortality [ Time Frame: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years ]

Recurrence, marginal ulcer. [ Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years ]

Weight loss expressed as Body Mass Index and Percentage of excess weight loss [ Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years ]

Remission or improvement of symptoms [ Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years ]

Secondary Outcome Measures:

Remission or improvement of comorbidities [ Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 years ]

Length of operative time which is defined as the time duration of operation measured in minutes from the first skin incision to the final closure of the skin incision [ Time Frame: It is measured in minutes from the first skin incision to the final closure of the skin incision at the time of revisional surgery under study. It is a transoperative measure of outcome of the surgery under study ]

Length of Hospital Stay which is a measured of surgical recovery quantified and reported in days. It is a hospital pre-discharge traditional measure of outcome. [ Time Frame: It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study. ]

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